Handling of CQA Team for routine activities of varies department i.e. Vendor Qualification, QMS Management, SOP’s and Policy Department, Audit and Compliance.  Monitoring and Guidance to All QC team as SME of QC to all site during Site Visit and Compliance.Perform the Self-inspection  of All site of Akums, Compliance Verification and Implementation of CAPA.Qualification and Audit for Vendors for RM, PM, External Lab and Calibration agency, Compliance Review and Approval of all sites in Akums Drugs for daily usage.Review the Annual Performance of RM, PM, Lab and Agency.Review the investigation of OOS and OOT.Handling the Regulatory Audit / MNC Audit of all sites of Akums Drugs.Daily Meeting with Cross Functional Team.MRM/QRM with all sites of Akums Drugs.eQMS 2.5, LIMS 4.5, BPCR issuance software, SAP interface Development and implementation in the 11 sites of Akums Drugs and Training to the Users & Master team.Handling of Core team of eQMS, LIMS, BIMS as Project Head.· IQ/OQ/PQ for eQMS, LIMS, BIMS.Script writing, protocol writing, SOP Preparation, impact Assessment, Gap Analysis, Risk Assessment of eQMS, LIMS, BIMS software.Responsible for training and trouble shootings of handling related to eQMS, LIMS, BIMS software.Computer System ValidationSoftware Development and Qualification and implementation in the 11 sites of Akums Drugs and Training to the Users & Master team.Across the organization of Akums Drugs & Pharmaceutical Ltd i.e. Change Control, CAPA, Deviation, Incident, Market Complaint, Vendor Qualification, Global CAPA Implementation,  Audit Management, OOS and OOT, Batch Issuance and Record management system (i.e. BMR/BPR issuance and retrieval through BIMS software ), Empower 3 and Lab Solutions etc. and DMS and LMS is under implementation.Data Management System and Training Management system is under development

Overall accountable for all Quality Control department functions. Review & updation of Quality controls SOPs,  Review & updation of Protocols & Report Review and approval of specification of starting materials, intermediates, API’s, finished productsto ensure compliance with compendia and company standards. Responsible for the Release & Rejection QC samples in absent of Head QC.  Regulatory audit compliance & CAPA.  Analytical data integrity and compliance.  To monitor contract laboratories for external samples testing. To ensure that finished products complies with regulatory requirement. Training and monitoring of effectiveness of all the quality controls personnel. Periodical internal audits to ensure the compliance with quality management system. Leading, managing, second line development & monitoring the performance of team members toensure efficiency in the various operations Vendor audits for raw materials and packaging materials. Handling of regulatory and customer inspections, which includes preparation for inspection and active participation in audits.  Responsible for technology transfer, Analyst validation Planning, Execution & Review of Analytical Tech transfer form R&D of various tests like, Assay, Related substances & Residual solvents etc. Conducting internal training as per the guidelines. Practicing quality standards with key emphasis on improving quality & improvement opportunities To ensure internal calibration schedule of the quality control instruments & equipment’s To ensure external calibration schedule of the quality control instruments & equipment’s. Review of IQ/OQ/PQ documents. Indent all QC related requirements (e.g. Chemicals/Reagents/HPLC Column etc.) Method and instruments troubleshooting. Investigation of OOS, OOT, Laboratory incidents and daily monitoring of analysis. Preparation of monthly report and presentation.

section incharge

section Head - FP, RM

instrument section incharge

RM and FP analysis

In Process Analysis